Attachment 5_SAMMC Guidelines May2010v1.1.pdf

S o u t h A f r i c a n N a t i o n a l G u i d e l i n e s f o r

M e d i c a l M a l e C i r c u m c i s i o n u n d e r L o c a l A n a e s t h e s i a

V E R S I O N 1

A u g u s t 2 0 1 0 drose Typewritten Text Attachment 5

South African National Guidelines for Medical Male Circumcision under Local Anaesthesia Version 1 (August 2010)

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Contents

Foreword vii Acknowledgements viii Abbreviations and acronyms used in this manual viii Introduction ix

1. BENEFITS AND RISKS OF MALE CIRCUMCISION

SUMMARY 1-1

INTRODUCTION 1-1

What is male circumcision? 1-1 How circumcision is performed 1-1

BENEFITS AND RISKS 1-2

Benefits 1-2 Risks 1-2

MALE CIRCUMCISION AND HIV INFECTION 1-3

The evidence linking male circumcision and HIV 1-3 Male circumcision and regional differences in HIV prevalence 1-3 Randomised controlled trials to assess the efficacy of male circumcision in reducing risk of HIV infection 1-4 Possible biological explanations for the protective effect of male circumcision 1-5 Protection for women 1-5 Other health benefits of circumcision 1-6 Acceptability of circumcision among African men 1-6

REFERENCES 1-7

2. LINKING MALE CIRCUMCISION TO OTHER MALE SEXUAL AND REPRODUCTIVE

HEALTH SERVICES

SUMMARY 2-1

MEN’S SEXUAL AND REPRODUCTIVE HEALTH NEEDS AND SERVICES 2-1

HIV Counselling and Testing (HCT) 2-3 Barriers to male sexual and reproductive health services 2-4

MEETING THE SEXUAL AND REPRODUCTIVE HEALTH NEEDS OF MEN 2-4

MEN’S ROLES IN WOMEN’S AND CHILDREN’S HEALTH 2-5

Who should provide sexual and reproductive health services and information to boys and men? 2-6

DETECTION AND TREATMENT OF SELECTED MALE SEXUAL AND

REPRODUCTIVE HEALTH PROBLEMS 2-7

Sexually transmitted infections 2-7 Balanitis 2-8 Phimosis 2-9 Paraphimosis 2-10 Urinary tract infections 2-11 Infertility 2-11

REFERENCES 2-12

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3. EDUCATING AND COUNSELLING CLIENTS, AND OBTAINING INFORMED

CONSENT

SUMMARY 3-1

EDUCATION ABOUT SEXUAL AND REPRODUCTIVE HEALTH AND MALE

CIRCUMCISION 3-1

Group education script 3-2

COUNSELLING 3-5

Basic facts about counselling 3-5 Confidentiality 3-5 Counselling skills 3-6

INFORMED CONSENT FOR SURGERY 3-10

General 3-10 Adolescent boys: consent and confidentiality 3-11 Documenting informed consent for surgery 3-12

INFANT CIRCUMCISION 3-12

INTEGRATION OF TRADITIONAL CIRCUMCISION EVENTS WITH CLINICAL

CIRCUMCISION 3-12

Appendix 3.1: Additional script for counselling reproductive health 3-14 Appendix 3.2: Sample information sheet for adult and adolescent clients 3-19 Appendix 3.3: Sample certificate of consent for adults and adolescents 3-23

4. FACILITIES AND SUPPLIES, SCREENING PATIENTS AND PREPARATIONS FOR

SURGERY

SUMMARY 4-1

EQUIPMENT AND SUPPLIES 4-1

MAINTENANCE AND REVIEW OF EQUIPMENT 4-3

SCREENING ADULT CLIENTS 4-4

History 4-4 Physical examination 4-5 HIV testing and informed consent for surgery 4-7

PREOPERATIVE WASHING BY THE PATIENT 4-7

SCRUBBING AND PUTTING ON PROTECTIVE CLOTHING 4-8

Whether to use a gown 4-10 Face masks and protective eyewear 4-10

Appendix 4.1: Sample client record form for adults and adolescents 4-11 Appendix 4.2: Sample disposable consumables for one adult male circumcision 4-14 Appendix 4.3: Detailed anatomy of the penis 4-15 Appendix 4.4: Selected anatomical abnormalities of the penis 4-18

5. SURGICAL PROCEDURES FOR ADULTS AND ADOLESCENTS

SUMMARY 5-1

SURGICAL SKILLS REQUIRED FOR SAFE CIRCUMCISION 5-1

Anatomy of the penis and choice of surgical technique 5-1 Tissue handling 5-1 Haemostasis 5-2 Diathermy 5-4 Suture material 5-5 Suturing 5-5 Tying knots 5-9

SKIN PREPARATION AND DRAPING 5-10

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Skin preparation with povidone iodine 5-10 Draping 5-10

ANAESTHESIA 5-11

Penile nerve supply 5-11 Maximum dose of local anaesthetic 5-12 Safe injection of local anaesthetic 5-13 Additional analgesia 5-13 Ring block technique 5-13 Modified approach used in high volume settings in South Africa 5-13

RETRACTION OF THE FORESKIN AND DEALING WITH ADHESIONS 5-14

MARKING THE LINE OF THE CIRCUMCISION 5-15

SURGICAL METHODS 5-16

Use of devices in adults and adolescents 5-16 Forceps-guided method of circumcision 5-16

DRESSING 5-22

Appendix 5.1: Variations in technique for minor abnormalities of the foreskin 5-23

6. CIRCUMCISION OF INFANTS AND CHILDREN

SUMMARY 6-1

SCREENING MALE BABIES AND YOUNG BOYS FOR CIRCUMCISION 6-1

CONSENT 6-2

PREPARATION 6-2

ANAESTHESIA 6-2

Safe injection of local anaesthetic 6-2 EMLA cream 6-4

GLUCOSE BY MOUTH 6-5

VITAMIN K 6-5

SKIN PREPARATION AND DRAPING 6-5

RETRACTION OF THE FORESKIN AND DIVISION OF ADHESIONS 6-5

PAEDIATRIC SURGICAL METHODS 6-6

Suture material 6-8 Dorsal slit method for children 6-9 The Plastibell method 6-12 The Mogen clamp method 6-15 The Gomco clamp method 6-18

REFERENCES 6-23

Appendix 6.1: Information for parents considering circumcision for their child 6-24 Appendix 6.2: Sample consent document for a minor 6-25

7. POSTOPERATIVE CARE AND MANAGEMENT OF COMPLICATIONS

SUMMARY 7-1

POSTOPERATIVE CARE 7-1

Postoperative monitoring 7-1 Instructions for the client 7-2 Transfer of client records 7-3

FOLLOW-UP VISITS 7-3

Routine follow-up 7-3 Emergency follow-up 7-4

RECOGNITION AND MANAGEMENT OF COMPLICATIONS 7-5

Organising referrals 7-5

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Complications occurring during surgery 7-5 Complications occurring within the first 48 hours after surgery 7-7 Complications occurring within the first two weeks after surgery 7-8 Late complications 7-9

Appendix 7.1: Sample postoperative instructions for men who have been circumcised 7-10

8. PREVENTION OF INFECTION

SUMMARY 8-1

BASIC CONCEPTS 8-1

STANDARD PRECAUTIONS 8-2

HAND HYGIENE 8-3

Washing hands with soap and water 8-4 Alcohol-based handrub 8-6 Surgical hand scrub 8-7

PERSONAL PROTECTIVE EQUIPMENT 8-7

Gloves 8-7 Masks, caps and protective eyewear 8-9 Aprons and the circumcision provider’s gown 8-9 Footwear 8-9 Immunisations 8-9

SAFE HANDLING OF HYPODERMIC NEEDLES AND SYRINGES 8-9

Tips for safe use of hypodermic needles and syringes 8-10 Sharps containers 8-10

PROCESSING OF INSTRUMENTS, ENVIRONMENTAL CLEANING AND

MANAGEMENT OF SPILLS 8-11

Disinfection 8-11 Cleaning 8-12 High-level disinfection 8-12 Sterilisation 8-12 Environmental cleaning 8-13 Management of spills 8-13

SAFE DISPOSAL OF INFECTIOUS WASTE MATERIALS 8-13

Waste management 8-14 Tips for safe handling and disposal of infectious waste 8-14 Disposing of sharp items 8-15 Burning waste containers 8-15 Encapsulating waste containers 8-15 Burying waste 8-15

POST-EXPOSURE PROPHYLAXIS 8-15

Managing occupational exposure to hepatitis B, hepatitis C and HIV 8-16 Management of exposure to hepatitis B 8-16 Management of exposure to hepatitis C 8-17 Post-exposure prophylaxis for HIV 8-17 Clinic staff should know their HIV status 8-21

REFERENCES 8-22

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9. MANAGING A CIRCUMCISION SERVICE

SUMMARY 9-1

RECORD KEEPING, MONITORING AND EVALUATION 9-1

Indicators 9-1 What is monitoring? 9-2 What is evaluation? 9-2 Why evaluate male circumcision programmes? 9-2 What is a monitoring system? 9-2 Monitoring performance in male circumcision programs 9-3 Evaluation 9-3 What are “good data”? 9-4

QUALITY ASSURANCE 9-5

SUPERVISION 9-5

The goal 9-6 The style 9-6 The process 9-6

Appendix 9.1: Sample stock card 9-9 Appendix 9.2: Sample stock-taking card for consumables 9-10 Appendix 9.3: Sample male circumcision adverse event form 9-11 Appendix 9.4: Sample male circumcision register 9-16

REFERENCES 9-17

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South African National Guidelines for Medical Male Circumcision under Local Anaesthesia Version 1 (August 2010)

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FOREWORD

South Africa is facing one of its greatest challenges, that of HIV and AIDS. The generalised epidemic has impacted hugely with around 5.2 million people being HIV infected1. There is no evidence to show that HIV prevention programs have impacted on HIV incidence.

However medical male circumcision (MMC) has been shown in recent randomised clinical trials to provide around 60% reduction in risk of HIV acquisition in men2.The results of these trials support the results of observational studies showing a strong correlation between high rates of male circumcision and lower rates of HIV prevalence3

Men have been marginalised from many HIV interventions that have largely focused on women and children. Women are more likely to be HIV-infected for social and biological reasons.

. Providing MMC in the public sector provides men with the opportunity of protecting themselves and their partners from HIV infection.

South Africa has practiced male circumcision traditionally for cultural and religious reasons for many years. Inter-provincial variations are from 67% in the Western Cape to 25.2% in Gauteng4. Similarly HIV rates differ from 25.8% in KwaZulu-Natal to 5.3% in the Western Cape5

Providing a package of HIV prevention services to men that includes HIV counselling and testing, STI screening and treatment, condom provision, medical male circumcision, risk reduction counselling and referral to male sexual health and reproductive services will strengthen HIV prevention efforts.

. Male circumcision is particularly effective in areas where there are low rates of circumcision and high HIV prevalence.

This document provides South Africa with guidelines for the provision of safe, effective and accessible voluntary medical male circumcision. The guidelines promote cost effective and efficient methods for rapid implementation of this life saving HIV prevention intervention.

Minister of Health Dr A. Motsoaledi

DATE

1 WHO-Afro 2008. Consultation on male circumcision and HIV prevention in the African region 2Auvert, B. et al. Randomised, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. Epub 25 October 2005; Gray, R. et al. Male circumcision for HIV prevention in men in Rakai, Uganda : A ramdomised trial. Lancet Infect Dis 2007: 369: 657-66; Bailey C, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: A randomised controlled trial. Lancet 2007: 369: 643-56.

3 Siegfried, N. et al. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev. 2003(3):CD003362; Weiss, H.A., Quigley, M.A., Hayes, R.J. Male circumcision and risk of HIV infection in sub- Saharan Africa: a systematic review and meta-analysis. AIDS. 2000 Oct 20;14(15):2361-70; Nagelkerke NJD, Moses S, de Vlas SJ and Bailey RC. Modeling the public health impact of male circumcision for HIV prevention in high prevalence areas in Africa. BMC Infectious Diseases 2007: 7:16, 13 March, 2007.

4 HSRC. 2009. South African National HIV Prevalence, incidence, behaviour and communication survey 2008: A turning tide among teenagers?

5 Ibid

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ACKNOWLEDGEMENTS

This manual has been adapted from the WHO/UNAIDS/JHPIEGO Manual for Male Circumcision under Local Anaesthesia (version 3.1) to support the South African National Department of Health’s medical male circumcision programme. This manual acknowledges the inputs of all individuals and organisations in the development of the document. The following organisations need special mention: NDOH, PDOH, CHAPS, Anova Health Institute, WHO (South Africa & Geneva), PEPFAR (JHPIEGO, USAID, CDC).

ABBREVIATIONS AND ACRONYMS USED IN THIS MANUAL

AIDS acquired immunodeficiency syndrome ALAT alanine amino transferase ARV antiretroviral drugs CDC Centres for Disease Control EMLA eutectic mixture of local anaesthetics HBV hepatitis B virus HCT HIV counselling and testing HCV hepatitis C virus HIV human immunodeficiency virus HPV human papilloma virus MMC medical male circumcision NDOH South African National Department of Health NRTI nucleoside reverse transcriptase inhibitor PEP post-exposure prophylaxis STI sexually transmitted infection TTT technical task team UNAIDS Joint United Nations Programme on HIV/AIDS USA United States of America USAID United States Agency for International Development WHO World Health Organisation

Medical Male Circumcision: male circumcision performed by trained circumcision providers in a health facility or a dedicated facility that is operated by health care professionals.

Circumcision Providers: health care professionals trained to provide male circumcision

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INTRODUCTION

Male circumcision has been shown to significantly lower the risk of heterosexual HIV transmission for men. The South African National Department of Health (NDOH) has endorsed Medical Male Circumcision (MMC) as an HIV prevention strategy for men in South Africa. The NDOH’s South African Guidelines for Medical Male Circumcision under Local Anaesthetic are intended for health care workers and program managers to provide universal, integrated, safe and accessible voluntary MMC services. The guidelines are adapted from those of the World Health Organisation (WHO). These guidelines support the National HIV/AIDS Strategic Plan 2007-2011 for South Africa (NSP) to reduce new infections by 50% by 2011.

Male circumcision has been shown to reduce men’s risk of becoming infected with HIV by between 51% and 60% in three randomized clinical trials (South Africa6, Uganda7 and Kenya8). The outcomes from these trials confirm cross-sectional epidemiological, observational and other studies that have shown that circumcised men have lower HIV prevalence than uncircumcised men9

There is no definite evidence that male circumcision reduces the risk of HIV transmission from men to women or between men who have sex with men. However there will be an indirect effect if HIV-prevalence in men is reduced.

. The results from the South African study showed a 60% lower incidence of HIV infection compared with those who delayed circumcision.

Male circumcision has been practiced in some cultural, traditional and religious communities for decades. Young men being circumcised is often a rite of passage into manhood. In South Africa some cultures practice full circumcision and others partial circumcision. Many men self report that they are circumcised however the foreskin is only partially removed.

Research findings suggest that the effectiveness of male circumcision in reducing the risk of female-to-male transmission only occurs when the foreskin is completely removed. There is no evidence that incomplete removal of the foreskin reduces the risk of HIV infection. Strong evidence has also been provided that failure to abstain from sexual activity for six weeks after circumcision increases the risk of transmission of HIV because of an unhealed wound.

In addition, resumption of sexual activity before wound healing in HIV positive men increases the risk of HIV transmission to a partner.

Studies conducted in 2001 and 2002 in South Africa indicate high levels of acceptability of male circumcision amongst men and women. More than 50% of men indicated they are

6 Auvert, B. et al. Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: the ANRS 1265 Trial. PLoS Med. 2005 Nov;2(11):e298. Epub 25 October 2005 7 Gray, R. et al. Male circumcision for HIV prevention in young men in Rakai, Uganda: A randomised trial.

Lancet Infect Dis 2007: 369: 657-66.

8 Bailey C, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: A randomised controlled trial. Lancet 2007: 369: 643-56.

9 Weiss HA, et al. Male circumcision and risk of HIV infection in sub-Saharan Africa: A systematic review and meta-analysis. AIDS 2000: 14: 2361-70; Siegfried N, et al. HIV and Male Circumcision – a systematic review with assessment of the quality of studies. Lancet Infect Dis 2005: 5:165-173; Siegfried N. et al. Male circumcision for prevention of heterosexual acquisition of HIV in men. Cochrane Database Syst Rev.

2003(3):CD003362.

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Page x willing to undergo male circumcision and more than 50% of women indicated they would be in favour of male circumcision 10

Male circumcision has been found to reduce other sexually transmitted infections like herpes, chancroid, syphilis and penile human papilloma virus (HPV) infection, which greatly reduces the risk of penile cancer in men as well as cervical cancer in female partners

11.

Cervical cancer remains the most common cancer among South African women. Male circumcision reduces other medical conditions like urinary tract infection in children, phymosis (adherence of the foreskin to the penis) and balanitis (yeast infection of the penis)12

There are possible biological explanations as to why male circumcision reduces the risk of HIV infection. These include; the foreskin has high concentrations of target cells that are very susceptible to HIV infection

MMC for HIV prevention is widely supported by the international community. The Southern African Development Community (SADC), WHO and UNAIDS have been at the forefront of efforts to provide policy and programmatic guidance around the introduction of medical male circumcision as part of a comprehensive package of HIV prevention. A SADC Expert Think Tank Meeting in 2006 identified that multiple and concurrent partners, combined with low levels of condom use and low levels of male circumcision within Southern Africa, as the key drivers of the epidemic. As a result of this meeting, SADC encouraged member states to prepare for the possible roll-out of MMC within their countries

; the underside of the foreskin is susceptible to micro tears and trauma during sexual intercourse that provide an entry point for HIV infection and, after complete circumcision, the skin of the penis thickens and becomes a stronger barrier (like skin on other parts of the body) to HIV infection.

WHO and UNAIDS convened the Montreux Technical Consultation in March 2007 to review the evidence around MMC for HIV prevention and to examine the policy and programmatic implications of introducing MMC. This consultation concluded that MMC should be recognised and promoted as an effective intervention for HIV prevention – in combination with other methods of HIV prevention, including partner reduction, consistent and correct

10 Lagarde, E. et al. Acceptability of male circumcision as a tool for preventing HIV infection in a highly infected community in South Africa. AIDS 2003: 17: 89 – 95.; Scott, BE et al. The acceptability of male circumcision as an HIV intervention among a rural Zulu population, KwaZulu-Natal, South Africa. AIDS Care April 2005: 17(3): 304 – 313.

11 Castellsagué X et al. The International Agency for Research on Cancer Multicenter Cervical Cancer Study Group. Male Circumcision, Penile Human Papillomavirus Infection, and Cervical Cancer in Female Partners. N Engl J Med 2002: 346: 1105-12.

12 Weiss HA, et al. Male circumcision and risk of syphilis, chancroid, and genital herpes: A systematic review and meta-analysis. Sex Transm Infect. 2006 Apr;82(2):101-9; discussion 10; Lavery L, et al. Effect of circumcision on incidence of human immunodeficiency virus type 1 and other sexually transmitted diseases: a prospective cohort study of trucking company employees in Kenya. J Infect Dis 1999; 180:330–336; Schoen EJ, et al. The highly protective effect of newborn circumcision against invasive penile cancer. P000;105:E36.

13 Patterson, B.K., Landay, A., Siegel, J.N., Flener, Z., Pessis, D., Chaviano, A., et al. Susceptibility to human immunodeficiency virus-1 infection of human foreskin and cervical tissue grown in explant culture. Am J Pathol. 2002 Sep;161(3):867-73.

14 SADC. 2006. Expert Think Tank Meeting on HIV Prevention in high prevalence countries of Southern Africa, Maseru, Lesotho 10 – 12 May.

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Page xi condom usage, HIV testing and counselling (HCT) and providing services for the treatment of sexually transmitted infections15

A review meeting, at the behest of the African Ministers of Health at the 57th Session of the WHO Regional Committee in August 2007, agreed that the evidence in favour of MMC is compelling and endorsed the recommendations of the WHO/UNAIDS Montreux Consultation. They encouraged member states to consider and customise the recommendations to suit their local contexts. They noted that traditional male circumcision plays an important role in the African region and strongly recommended that regional and country consultations be held to review and assess the role of traditional practitioners, determine synergies, investigate possible models of collaboration and make specific recommendations on their role to maximise the contribution of male circumcision to HIV prevention

Following the SANAC plenary meeting in October 2008, SANAC convened a series of consultations on MMC across and within sectors and adopted a resolution on the way forward in relation to MMC. In February 2009 SANAC mandated the NDOH to prepare a draft policy on the scaling up of MMC services within the public health sector. In preparation for the development of the policy, consultations have been undertaken with traditional leaders and healers on MMC and consultations are ongoing with all sectors to get input into the policy making process.

Operational lessons continue to be learnt from the male circumcision project being undertaken in Orange Farm, as a follow-up to the Orange Farm RCT. The SANAC Communications Technical Task Team (TTT) has developed a draft communication framework for MMC that will form the basis for the development of a national communication strategy for MMC. The SANAC Prevention TTT has been mandated to continue the consultative process with religious, traditional and other stakeholders. These consultations should not delay the MMC implementation process as part of government health service delivery under the auspices of male sexual and reproductive health services.

HIV is one of the greatest challenges facing South Africa today. South Africa has a generalised HIV epidemic with an estimated 5.2 million people (10.6% of the population) infected and an estimated HIV prevalence rate of 29.4% amongst pregnant women. HIV prevalence varies among provinces from 25.8% in KwaZulu-Natal and 23.1% in Mpumalanga to 5.3% in the Western Cape and 9.0% in the Northern Cape17. Male circumcision is not commonly practiced in the first two (KZN and Mpumalanga) but more common in the Western and Northern Cape. It is further estimated that 85% of infections occur through heterosexual sex18

In South Africa between 32% and 45% of men report being circumcised (medical and traditional), with circumcision rates being the highest in the Western Cape (67.5%) and the

. In South Africa, HIV prevalence amongst men peaks in the age cohort of 30 – 34 at 25.8%, while amongst women HIV prevalence peaks in the age cohort 25 – 29 at 32.7%.

15 WHO/UNAIDS. 2007. New data on male circumcision and HIV prevention: Policy and programme implications. Technical Consultation on Male Circumcision and HIV Prevention: Research Implications for Policy and Programming, Montreux, 6 – 8 March 2007.

16 WHO-Afro. 2008. Consultation on male circumcision and HIV prevention in the African Region.

17 HSRC. 2009. South African National HIV Survey 2008.

18 HSRC. 2009. South African National HIV Survey; NDOH 2006 National HIV and Syphilis Antenatal Prevalence Survey in South Africa; UNAIDS estimates 5.7 million in 2007

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Page xii lowest in KwaZulu-Natal (26.8%) and Gauteng (25.2%). Reported levels of circumcision are highest amongst men over the age of 30 (53%)19

Based on the data from clinical trials, it has been estimated that routine MMC across sub- Saharan Africa could prevent up to six million new HIV infections and three million deaths in the next two decades

MMC will be provided as an integral part of male sexual and reproductive health services that will embrace HIV prevention, care and treatment.

. The impact of male circumcision would be greater in countries with high HIV prevalence and low to moderate male circumcision rates, both factors that apply to South Africa.

There is increased demand for male circumcision in several countries with a high incidence of HIV, but there is little technical guidance on how services can be safely expanded given the limited resources available. Reports of high complication rates following circumcisions performed on young men by traditional practitioners in southern and eastern Africa are common, but the true incidence is not known. Technical guidance on the provision of safe male circumcision services is therefore necessary. Although circumcisions are widely performed by surgeons and general practitioners in appropriate clinical environments, resources are not currently adequate to meet the anticipated increased demand.

These technical guidelines on male circumcision are aimed at providers of male circumcision services and programme managers. The methods described have been selected on the basis of their safety and practicality for use in resource-limited settings and do not include all possible methods. These guidelines form part of a comprehensive package. This includes training guides and materials, as well as a male circumcision quality improvement framework for use by providers, programme managers and national medical authorities to ensure high-quality services. While providing detailed technical information on the different surgical approaches, the guidelines also address broader issues of male sexual and reproductive health and emphasises that male circumcision must be set within the context of other strategies for reducing the risk of HIV infection. A full description of best practices for surgery and anaesthesia in resource-limited settings can be found in the WHO publication: Surgical care at the district hospital (Geneva, WHO, 2003).

These guidelines are an adaptation of those developed by the WHO, in collaboration with UNAIDS and JHPIEGO, as part of work to support countries in providing safe male circumcision services. This work also intends ensuring that circumcised men do not perceive themselves as fully protected against HIV and other sexually transmitted infections and consequently forgo other HIV risk-reduction strategies.

These guidelines were developed from reproductive health and surgery training materials, as well as on the basis of experience with service provision in Africa, the Eastern Mediterranean and developed countries. In particular, the experience from the Orange Farm project has been incorporated, providing exceptional and relevant South African input. The guidelines and materials were reviewed by actual and potential providers of male

19 Department of Health, Medical Research Council, OrcMarco. 2007. South Africa Demographic and Health Survey 2003. Pretoria: Department of Health.

20 Scott, B.E; Weiss, H.A; Viljoen, J.I. (2006). The acceptability of male circumcision as an HIV intervention among a rural Zulu population, KwaZulu-Natal, South Africa. In: AIDS Care, April 2005; 17(3): 304 – 313.

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Page xiii circumcision services representing a range of health care and cultural settings where demand for male circumcision services is high.

These guidelines are one of several documents and guidelines developed by WHO, UNAIDS and partners to assist countries to develop and implement programmes for safe medical male circumcision for HIV prevention, within the context of their existing HIV prevention activities and sexual and reproductive health programmes. All documents can be downloaded from the Clearinghouse on Male Circumcision for HIV Prevention (www.malecircumcision.org), a web site created to share technical and policy guidance, knowledge, tools and experience relevant to implementing male circumcision programmes.

The most relevant documents include:

New data on male circumcision and HIV prevention: Policy and programme implications − provides guidance to policy makers and programme managers on issues that need to be considered and addressed when planning for programme scale-up.

Operational guidance for scaling up male circumcision services for HIV prevention:

Provides operational and programmatic guidance to decision-makers, programme managers and technical support agencies on scaling up programmes in the public and private sectors.

Male circumcision quality assurance: A guide to enhancing the safety and quality of services − outlines the roles and responsibilities of national and district programme managers for implementing safe, quality male circumcision services. It also provides guidance for the planning of a national quality assurance programme. It defines ten quality standards against which the quality of services can be measured and used as part of a continuous process of service improvement. The guide is supplemented by the Male circumcision services quality assessment toolkit ; this is used by facility managers and providers to assess their performance. It can also be used by national and district managers to conduct external assessments of facilities. The toolkit includes a scoring tool, where users can enter assessment findings and monitor progress towards meeting the standards.

Considerations for implementing models for optimizing the volume and efficiency (MOVE) of male circumcision services for HIV prevention. Provides guidance on the MOVE model, developed in South Africa, to help programmes improve the efficiency of clinical and surgical activities so that they can strengthen their capacity to meet demand for male circumcision services. It addresses clinical techniques, staffing, facility space, client scheduling and flow, commodities management, cost efficiencies and quality assurance. It also includes detailed model lists of equipment and supplies required to support a male circumcision programme.

A guide to indicators for male circumcision programmes in the formal health care system: Lists indicators that programmes can use to monitor and evaluate progress towards their programme objectives. Adaptable to different country situations, the guide includes indicators of demand for, and supply of, male circumcision services, as well as measures to assess secondary effects of the programme, such as changes in sexual behaviours at the individual and community levels.

http://www.malecircumcision.org/�

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The document comprises non-clinical (Chapters 1 – 3), clinical (Chapters 4 – 8) and managerial (Chapter 9) guidelines. The non-clinical chapters provide a background on MMC and HIV infection, describe HCT and linking MMC to HIV services and male sexual and reproductive health services and provide guidance on MMC counselling and informed consent. The clinical guidelines describe the procedures required prior to surgery, the surgical techniques for adults and children, post-operative care and prevention of infection. Chapter 8 describes the procedures required to manage a circumcision service including administrative and quality assurance and control.

South African National Guidelines for Medical Male Circumcision under Local Anaesthesia Version 1 (August 2010)

Benefits and risks of male circumcision Chapter 1-1

Chapter 1: Benefits and risks of male circumcision

SUMMARY

• Male circumcision surgically removes the foreskin, the fold of skin that covers the head of the penis (glans).

• The benefits of male circumcision include a reduced risk of urinary tract infections in childhood, a reduced risk of ulcerative sexually transmitted diseases in adulthood, protection against penile cancer, a reduced risk of cervical cancer in female sex partners, and prevention of balanitis (inflammation of the glans), posthitis (inflammation of the foreskin), phimosis (inability to retract the foreskin) and paraphimosis (inability to return the retracted foreskin to its original location).

• Complication rates after medical male circumcision (MMC) are very low when it is performed by well equipped and trained health care providers.

• Several regional and global studies since the 1980s have noted a lower risk of HIV infection in circumcised men, as well as lower HIV prevalence in populations where male circumcision is common.

• Randomised controlled trials in South Africa, Kenya and Uganda have demonstrated that male circumcision reduces a man’s risk of HIV infection by 60%.

INTRODUCTION

What is male circumcision?

Male circumcision removes the foreskin, the fold of skin that covers the head of the penis, surgically. It is widely practised for religious and traditional reasons, often within the first two weeks after birth, or at the beginning of adolescence as a rite of passage into adulthood. It is also done for medical reasons to treat problems involving the foreskin.

How male circumcision is performed

During a male circumcision, the foreskin is freed from the head of the penis (glans) and removed. In a newborn baby, circumcision is simpler and quicker than in adolescents and adults. Superficial wound healing after male circumcision in adults generally takes 5 – 7 days. However, about 4 – 6 weeks are needed for the wound to heal fully. In babies and young boys, the healing time is considerably shorter, around one week.

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BENEFITS AND RISKS

The necessity for male circumcision is a subject of heated debate in many countries. In some settings male circumcision is widely performed for religious or cultural reasons, while in others it is performed mainly for medical reasons. Every potential client or parent has to get full information about the benefits and risks of circumcision to make an informed decision.

The decision of an adult or young man to be circumcised, and the decision of a parent to have his or her son circumcised, should be based on culture, religion, personal preference, and based on information from a health care worker.

Benefits

If male circumcision is being done for reasons other than the treatment of a medical problem, the health benefits are primarily preventive, and may only be felt long after the procedure. Male circumcision may reduce the risk of getting some infections and related complications, but does not guarantee complete protection.

Some of these conditions are common, while others are less so, and the degree of risk for the person is likely to depend on his behaviour and where he lives. Although the strength of the evidence varies by disease, the benefits of male circumcision include:

• It is easier to keep the penis clean.

• It reduces the risk of urinary tract infections in childhood.1

• It prevents inflammation of the glans (balanitis) and the foreskin (posthitis).

• It prevents the potential development of scar tissue on the foreskin, which may lead to phimosis (inability to retract the foreskin) and paraphimosis (swelling of the retracted foreskin so that the foreskin cannot return to its normal position).

• It reduces the risk of some sexually transmitted infections (STIs), especially ulcerative diseases, such as chancroid and syphilis.2, 3

• It reduces the risk of getting infected with human immunodeficiency virus (HIV).

4, 5, 6, 7, 8

• It reduces the risk of penile cancer.

9, 10

• It reduces the risk of cancer of the cervix in female sex partners.

Risks

As with any surgical procedure, risks are associated with male circumcision. While the benefits of male circumcision may be wide-ranging and long-term, any problems generally occur during or soon after the procedure. They include:

• pain;

• bleeding;

• haematoma (formation of a blood clot under the skin);

• infection at the site of the circumcision;

• increased sensitivity of the glans penis for the first few months after the procedure;

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• irritation of the glans;

• meatitis (inflammation of the opening of the urethra);

• injury to the penis;

• adverse reaction to the anaesthetic used during the male circumcision.

These complications are rare when the circumcision is done by well trained, adequately equipped, experienced health care personnel, and are usually easily and rapidly resolved. Data from controlled trials show that fewer than 1 in 50 circumcisions result in complications.4, 6

MALE CIRCUMCISION AND HIV INFECTION

Currently there is great interest in the role of male circumcision in preventing HIV infection. Research has shown a lower risk of infection in circumcised compared with uncircumcised men, as well as a lower prevalence of HIV infection in populations where male circumcision is common. These results led the WHO and the Joint United Nations Programme on HIV/AIDS (UNAIDS) to promote male circumcision as an additional method of HIV prevention and that countries or settings with generalised HIV epidemics and low prevalence of male circumcision must scale up MMC services urgently.12

The evidence linking male circumcision and HIV

A systematic review and meta-analysis of 28 published studies found that uncircumcised men are two to three times more likely to be infected with HIV than circumcised men, with the difference being most pronounced in men with high exposure to HIV infection. A sub-analysis of 10 African studies of men considered to be at high risk of becoming infected, found a 3.4 times higher incidence of HIV infection among those who were uncircumcised. In a prospective study in Uganda of HIV-negative men whose partners were HIV-positive, none of 50 circumcised men became infected within two years, compared with 40 of 137 uncircumcised men.13

Male circumcision and regional differences in HIV prevalence

The sub-Saharan Africa regions in where men are more commonly circumcised overlap with areas of lower HIV prevalence. An extensive UNAIDS study investigated behavioural and other factors that could explain the large differences in HIV prevalence across different African regions.14

A low prevalence of male circumcision and a high prevalence of genital herpes (which is more common in uncircumcised men) emerged as the principal determinants of the differences in HIV rates.

Table 1.1 shows the prevalence of HIV infection in several countries with low or high rates of male circumcision. Countries in sub-Saharan Africa where male circumcision is common (more than 80%) generally have HIV prevalence levels well below those of countries where male circumcision is less common (less than 20%), despite the presence of

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Benefits and risks of male circumcision Chapter 1-4 other risk factors for heterosexual HIV transmission, such as high frequency of multiple sexual partners, low rates of condom use and high prevalence of other STIs. HIV prevalence in the countries of south and south-east Asia where nearly all men are circumcised (Bangladesh, Indonesia, Pakistan, Philippines) remains low, despite patterns of risk factors for HIV and other STIs similar to those found elsewhere in the region.

Table 1.1: HIV prevalence according to rates of male circumcision

Low circumcision rate (<20%)

High circumcision rate (>80%)

Country HIV prevalence

Country HIV prevalence

Sub-Saharan Africa

Botswana 24.1 Benin 1.8 Malawi 14.1 Cameroon 5.4

Mozambique 16.1 Democratic Republic of Congo

3.2

Namibia 19.6 Gabon 7.9 Rwanda 3.1 Gambia 2.4

Swaziland 33.4 Ghana 2.3 Zambia 17.0 Guinea 1.5

Zimbabwe 20.1 Kenya 6.1 Liberia 5.9 Nigeria 3.9 Sierra Leone 1.6 South and south-east Asia

Cambodia 1.6 Bangladesh <0.1 India 0.9 Indonesia 0.1

Myanmar 1.3 Pakistan 0.1 Nepal 0.5 Philippines <0.1

Thailand 1.4 Source: Updated from Halperin & Bailey,15 using most recent UNAIDS data.16

A study in India followed 2 298 men attending three STI clinics.17

Circumcised men showed lower incidence of HIV infection was, although rates of STIs, such as syphilis and gonorrhoea, were similar.

The similar incidence of STIs in the two groups shows similar sexual risk behaviour, and suggests a biological rather than a behavioural explanation for the observed lower rate of HIV. However, it is important to note that, of the 191 circumcised men, 62% were Muslim.

When non-Muslim men were assessed separately, the circumcised group was small and no significant protective effect was found. This shows the difficulty of separating the effect of male circumcision from other cultural factors. Only randomised controlled trials can determine the efficacy of male circumcision in reducing the risk of HIV infection.

Randomised controlled trials to assess the efficacy of male circumcision in reducing risk of HIV infection

In July 2005 the results of the Orange Farm Intervention Trial in South Africa were made public and were published in November 2005. This was the first report from a randomised controlled trial of male

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Benefits and risks of male circumcision Chapter 1-5 circumcision as a means to prevent HIV infection. A total of 3 274 uninfected men, aged between 18 and 24, were randomly assigned to undergo circumcision either immediately or after 21 months. The incidence of HIV infection was 60% lower among those who were circumcised. On the strength of these results, the Independent Data Monitoring Committee recommended that the men initially assigned to the delayed circumcision group should be offered the procedure immediately, without waiting the full 21 months.

Two further trials on male circumcision and HIV infection were stopped in December 2006 and published in early 2007. Both trials involved random allocation of HIV-negative volunteers to either immediate circumcision, done by trained medical professionals in a clinic (intervention group), or circumcision delayed for two years (control group). The first trial, in Kisumu, western Kenya, was done among men aged between 18 and 24 and showed a 53% reduction in HIV incidence. The second study, in Rakai, Uganda, among men aged between 15 and 49, showed a 51% reduction in HIV incidence. After the release of the study results, the men in both non-intervention groups were offered circumcision immediately.

Possible biological explanations for the protective effect of male circumcision

The primary cells through which HIV enters the body are Langerhans cells. These cells are present in high density in the epithelium of the inner foreskin, and are close to the surface because the layer of keratin is thin.18, 19

In an in vitro study, viral uptake by cells from the mucosal surface of foreskin was seven times more efficient than that by tissue from the female cervix.20 The inner mucosal surface of the foreskin lacks the thick layer of keratin that covers most exposed skin. This leaves numerous mucosal Langerhans cells and other immune cell targets easily accessible to HIV infection.21

The highly vascularised foreskin mucosa, and in particular the frenulum, can tear and bleed during intercourse. These micro-injuries allow easy access of HIV to the bloodstream.

Another factor that may help entry of the virus is the presence of an ulcerative STI, such as herpes simplex, chancroid or syphilis, which tend to be more common in uncircumcised men.

Protection for women

A study in Uganda showed lower rates of male-to-female transmission of HIV if the man was circumcised. Among 47 couples in which the circumcised male partner was infected with HIV and whose viral load was below 50 000 copies per ml, none of the female partners became infected in two years. By contrast, 26 of the 147 women whose HIV-infected partners were not circumcised became infected.

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A subsequent randomised controlled trial of circumcision among men with HIV infection did not confirm this result. It showed there might be a higher risk of HIV transmission to women in the first two years after the operation.22

A further observational study has shown a 40% lower risk of HIV infection in couples where the male partner was infected and the female partner not infected with HIV, but the risk reduction was not significant.23

Other health benefits of circumcision

A multi-country study24 found a lower prevalence of human papillomavirus (HPV) infection in circumcised men than in uncircumcised men. HPV infection is a necessary causal factor for cervical cancer and is associated with an increased risk of cancer of the vulva, vagina and anus in women, and of the penis and anus in men. Prospective studies have shown that circumcised men are less likely to have HPV infection.25,26,27

The incidence of invasive penile cancer is significantly lower in circumcised men than in uncircumcised men, though this condition is extremely rare.28

,10

Acceptability of circumcision among African men

Surveys and qualitative studies among young as well as older men in six African countries have found that a considerable proportion expressed interest in circumcision, ranging from 45% in Harare, Zimbabwe, to over 80% in a large survey in Botswana.29

These studies show that many men would willingly undergo circumcision if it could be performed safely and at reasonable cost.

In the surveys, the men reported that their main interest in circumcision was related to hygiene, infection control and, for some, a belief that condom use is easier for men who are circumcised.

Studies conducted in 2001 and 2002 in South Africa indicate high levels of acceptability of male circumcision amongst both men and women. More than 50% of men indicated that they are willing to undergo circumcision and more than 50% of women indicating that they would be in favour of male circumcision.

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REFERENCES

1 Wiswell TE, Hachey WE. Urinary tract infections and the uncircumcised state. Clin Pediatr 1993;

32: 130-4.

2 Nasio JM et al. Genital ulcer disease among STD clinic attenders in Nairobi: association with HIV-1 and circumcision status. Int J STD AIDS 1996; 7: 410-414.

3 Cook LS, Koutsky LA, Holmes KK. Circumcision and sexually transmitted diseases. Am J Public Health 1994; 84: 197-201.

4 Krieger J et al. Adult male circumcision: results of a standardised procedure in Kisumu District, Kenya. BJU International 2005; 96: 1109-1113.

5 Weiss H, Quigley M, Hayes R. Male circumcision and risk of HIV infection in sub-Saharan Africa: a systematic review and meta-analysis. AIDS 2000; 14: 2361-2370.

6 Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, Puren A. Randomised, controlled intervention trial of male circumcision for reduction of HIV infection risk: The ANRS 1265 Trial.

PLoS Medicine 2005;2(11):e298.

7 Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet 2007;369:643- 656.

8 Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet 2007; 369: 657-666.

9 American Academy of Pediatrics. Report of the task force on circumcision. Pediatrics 1989; 84:

388-391.

10 Dodge OG, Kaviti JN. Male circumcision among the peoples of East Africa and the incidence of genital cancer. East Afr Med J 1965; 42: 98-105.

11 Agarwal SS et al. Role of male behavior in cervical carcinogenesis among women with one lifetime sexual partner. Cancer 1993; 72: 166-169.

12 World Health Organization and Joint United Nations Programme on AIDS. New Data on Male Circumcision and HIV Prevention: Policy and Programme Implications. World Health Organization, Geneva, 2007 (http://www.who.int/hiv/mediacentre/news68/en/index.html)

13 Gray RH, Kiwanuka N, Quinn TC et al. Male circumcision and HIV acquisition and transmission:

cohort studies in Rakai, Uganda. Rakai Project Team. AIDS 2000;14:2371-81.

14 Auvert B, Buve A, Ferry B, Carael M, Morison L, Lagarde E et al. Ecological and individual level analysis of risk factors for HIV infection in four urban populations in sub-Saharan Africa with different levels of HIV infection. AIDS 2001;15:S15-30.

15 Halperin DT, Bailey RC. Male circumcision and HIV infection: 10 years and counting. Lancet 1999;354:1813-1815.

16 2006 Report on the global AIDS epidemic. Geneva: Joint United Nations Programme on HIV/AIDS;

2006.

17 Reynolds SJ et al. Male circumcision and risk of HIV-1 and other sexually transmitted infections in India. Lancet 2004; 363(9414):1039-40.

18 Soilleux EJ, Coleman N. Expression of DC-SIGN in human foreskin may facilitate sexual transmission of HIV. J Clin Pathol 2004; 57: 77-78.

19 Hussain LA, Lehner T. Comparative investigation of Langerhans cells and potential receptors for HIV in oral, genitourinary and rectal epithelia. Immunology 1995; 85: 475-484.

20 Estrada CR et al. Biologic mechanisms of HIV infection of human foreskin: Implications for transmission. J Urol 2002; 147 (Suppl 4).

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